NCT05994586

Brief Summary

The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 9, 2023

Last Update Submit

August 9, 2023

Conditions

Diabetes in AdolescencePreDiabetes

Keywords

Type II diabetesPrediabetesDisorders of Carbohydrate MetabolismChokeberryElderberry

Outcome Measures

Primary Outcomes (3)

  • Glucose level

    Comparison of glucose level

    Baseline, 2 months, 3 months, 5 months

  • Insulin level

    Comparison of insulin level

    Baseline, 2 months, 3 months, 5 months

  • Discomfort related to metformin side effects

    Based on questionnaire

    Baseline, 2 months, 3 months, 5 months

Secondary Outcomes (3)

  • Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)

    Baseline, 2 months, 3 months, 5 months

  • hsCRP level

    Baseline, 2 months, 3 months, 5 months

  • HbA1c level

    Baseline, 2 months, 3 months, 5 months

Study Arms (4)

AP029 mix - type II diabetes

EXPERIMENTAL

Patients with type II diabetes receiving metformin for up to 5 months

Dietary Supplement: AP029 mix

AP029 mix - prediabetes

EXPERIMENTAL

Patients with pre-diabetic

Dietary Supplement: AP029 mix

Placebo - type II diabetes

PLACEBO COMPARATOR

Patients with type II diabetes receiving metformin for up to 5 months

Other: Placebo

Placebo - prediabetes

PLACEBO COMPARATOR

Patients with pre-diabetic

Other: Placebo

Interventions

AP029 mixDIETARY_SUPPLEMENT

Polyphenol-rich plant extracts Twice a day

AP029 mix - prediabetesAP029 mix - type II diabetes
PlaceboOTHER

Twice a day

Placebo - prediabetesPlacebo - type II diabetes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men, 18-75 years old
  • Patients diagnosed with type II diabetes mellitus
  • Patients on metformin treatment up to 5 months
  • BMI 20-35 kg/m2
  • Signed informed consent
  • Women and men, 18-75 years old
  • BMI 20-35 kg/m2
  • Fasting blood glucose levels between 100 mg/dl and 125 mg/dl (5.6-6.9 mmol/l)
  • Signed informed consent

You may not qualify if:

  • Patients diagnosed with type I diabetes
  • Patients receiving insulin or other anti-diabetic medications
  • Women who are pregnant, planning to become pregnant during the study, or breastfeeding
  • Surgery within the last 6 months
  • Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins
  • Intake of supplements containing: white mulberry, chromium, berberine
  • Patients receiving glucocorticosteroids, immunosuppressants
  • Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant
  • Acute inflammation (C-reactive protein \>20mg/dl)
  • Patients diagnosed with type I, II, LADA diabetes
  • Patients receiving insulin or other anti-diabetic medications
  • Women who are pregnant, planning to become pregnant during the study, or breastfeeding
  • Surgery within the last 6 months
  • Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins
  • Intake of supplements containing: white mulberry, chromium, berberine
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pomorskie Centrum Reumatologiczne im. dr Jadwigi Titz-Kosko

Sopot, 81-820, Poland

RECRUITING

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

May 25, 2023

Primary Completion

November 26, 2023

Study Completion

November 26, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)